Women's Global Health Imperative (WGHI), RTI International, Berkeley, California, USA.
Population Council, New York, New York, USA.
J Womens Health (Larchmt). 2022 Jul;31(7):1029-1039. doi: 10.1089/jwh.2021.0121. Epub 2021 Oct 19.
The monthly dapivirine vaginal ring provides partial protection against HIV, and a longer duration ring may reduce user burden and improve adherence. We examined acceptability and preference for 3-month versus 1-month rings for HIV-1 risk reduction in a phase 1 clinical trial. In Microbicide Trials Network-036/International Partnership for Microbicides 047, 49 HIV-negative participants aged 18-45 were randomized to one of two 3-month rings or the 1-month ring. Acceptability ratings were collected at enrollment, week 4, and study exit (week 13). At exit, ring preference was assessed quantitatively among all participants and a randomly selected subset of 24 participants completed in-depth interviews. Quantitative and qualitative findings were integrated to explore factors influencing acceptability and preference. Acceptability of each ring was initially moderate and increased during the trial. Ratings were lower in the 3-month ring arms than the 1-month arm at each time point, including baseline. Most participants (34/47; 72%) preferred a 3-month ring at exit; however, this proportion was significantly lower within some subgroups characterized by site, education, race/ethnicity, and experiences with ring use. Qualitative interviews revealed reservations about hygiene and safety of the 3-month ring, including discomfort with use during menses, but these were usually outweighed by its increased convenience. Both ring durations were highly acceptable at study exit. Although most participants preferred a 3-month ring, preference was more divided in certain subgroups, highlighting the benefit of offering different duration options. Providing additional support to address concerns about hygiene and safety may improve acceptability of a 3-month vaginal ring.
每月使用一次的 dapivirine 阴道环能提供部分 HIV 防护,使用时间更长的阴道环可能会降低使用者的负担并提高其依从性。我们在一项 1 期临床试验中研究了 3 个月和 1 个月阴道环用于 HIV-1 减少风险的可接受性和偏好性。在 Microbicide Trials Network-036/International Partnership for Microbicides 047 研究中,49 名年龄在 18-45 岁的 HIV 阴性参与者被随机分配到两个 3 个月阴道环组或 1 个月阴道环组。在入组时、第 4 周和研究结束时(第 13 周)收集了可接受性评分。在结束时,所有参与者和随机选择的 24 名参与者的一个子集都进行了定量的环偏好评估,并完成了深入访谈。将定量和定性研究结果结合起来,以探讨影响可接受性和偏好的因素。每个阴道环的初始可接受性为中等水平,在试验过程中逐渐提高。在每个时间点,包括基线时,3 个月阴道环组的评分均低于 1 个月阴道环组。大多数参与者(34/47;72%)在结束时更喜欢 3 个月阴道环;然而,在某些特征为地点、教育、种族/民族和使用环经验的亚组中,这一比例显著较低。定性访谈揭示了对 3 个月阴道环的卫生和安全性的保留意见,包括在经期时使用的不适感,但这些意见通常被其增加的便利性所抵消。两种环在研究结束时都具有高度可接受性。尽管大多数参与者更喜欢 3 个月阴道环,但在某些亚组中,偏好更为分散,这突出了提供不同使用时间选择的好处。提供额外的支持以解决卫生和安全方面的问题可能会提高 3 个月阴道环的可接受性。